VerSys® 7818-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024362147), received between Nov 12, 2021 and Feb 13, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K955473); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2023Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16362485 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL LEFT PARTIAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED TO TOTAL ARTHROPLASTY APPROXIMATELY 3 YEARS LATER DUE TO PAIN AND ARTHRITIC DISEASE PROGRESSION. DURING THE REVISION, SIGNIFICANT HO WAS ENCOUNTERED AND REMOVED FROM THE POSTERIOR CAPSULE. THE HEAD WAS EXCHANGED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Extraskeletal ossification

  MAUDE report 12802787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955473. One submission often covers many models, so check the product and lot details in each record.

• Z-1169-2016 · Jan 11, 2016 · Terminated
  Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS
• Z-1101-2016 · Jan 11, 2016 · Terminated
  Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR
• Z-1165-2016 · Jan 11, 2016 · Terminated
  Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE
• Z-2547-2014 · Jul 22, 2014 · Terminated
  Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL H
• Z-1029-2014 · Oct 11, 2013 · Terminated
  12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX S